FDA 510(k)

HomeSleepTest (HST, HST REM+)

K-Number: K240700 · 2024-12-08

Decision Date2024-12-08

Product CodeOLV

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

HomeSleepTest (HST, HST REM+) is the device name listed in this FDA 510(k) record. The listed applicant is Somnomedics GmbH. It received FDA 510(k) clearance on 2024-12-08 under 510(k) number K240700. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HomeSleepTest (HST, HST REM+)?

HomeSleepTest (HST, HST REM+) is a medical device that received FDA 510(k) clearance on 2024-12-08. The listed applicant is Somnomedics GmbH. The 510(k) number is K240700.

When did HomeSleepTest (HST, HST REM+) receive FDA 510(k) clearance?

HomeSleepTest (HST, HST REM+) received FDA 510(k) clearance on 2024-12-08, under 510(k) number K240700.

Who is the listed applicant for HomeSleepTest (HST, HST REM+)?

The FDA 510(k) record lists Somnomedics GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HomeSleepTest (HST, HST REM+)?

The FDA product code for HomeSleepTest (HST, HST REM+) is OLV.

Other records listing Somnomedics GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231104ABPMpro K212325EEG-acp K201054SOMNOscreen plus

Related Devices (Code: OLV)

K260585Noxturnal WebNox Medical Ehf K242447Falcon HSTCompumedics Limited K241288Noxturnal WebNox Medical Ehf K213007Cerebra Sleep SystemCerebra Medical , Ltd.K201054SOMNOscreen plusSomnomedics GmbH K192624ApneaTrakCadwell Industries, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.